- Provides the clinical benefits of baclofen in rapidly dissolvable granule formulation with flexible dosing for individual patient needs

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the commercial launch of LYVISPAH^®, a baclofen oral granules (5, 10 and 20 mg) specialty product approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of spasticity related to multiple sclerosis and other spinal cord disorders.

LYVISPAH is bioequivalent to oral baclofen tablets and provides flexible, customized dosing with 5mg, 10mg and 20mg single-dose packets of granules. The rapidly dissolving flavored granules provide an alternative for patients with spasticity who also have difficulty swallowing pills. The product can be administered three ways: poured directly into the patient’s mouth with or without water, mixed with liquids or foods, or through an enteral feeding tube.

“This is the first Specialty product launch for the business since Rytary^® (carbidopa and levodopa) in 2015, and the first in a cadence of new branded launches planned over the next several years. The launch of LYVISPAH is the next step in our strategy to expand our Specialty business and drive accelerated growth. As we build our position in the neurology space, we see a clear need for more options to treat spasticity resulting from multiple sclerosis and other spinal cord disorders based on individual patient’s needs. We believe LYVISPAH provides that option,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

In January, Amneal announced the acquisition of Saol Therapeutics’ baclofen franchise and the expansion of its neurology presence into spasticity with LYVISPAH and Lioresal^® (baclofen), a baclofen product delivered through an implantable intrathecal pump for use in the management of severe spasticity of cerebral or spinal origin for the institutional market.

Baclofen, a skeletal muscle relaxant, is well established for the treatment of spasticity and spinal cord injuries. It was first approved by the FDA in 1977. The FDA-approved labeling says that LYVISPAH oral granules are indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity, and may also be of some value in patients with spinal cord injuries and other spinal cord diseases. LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

LYVISPAH will be available through both specialty and retail channels upon launch, with a full patient support program. The Company has partnered with BlinkRx, a patient access company, to support patients on LYVISPAH with services, such as free home delivery.

According to IQVIA^®, U.S. annual sales for baclofen for the 12 months ended March 2022 were $130 million.

INDICATION

• LYVISPAH (baclofen) oral granules is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
• LYVISPAH may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Limitations of Use: LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

Contraindication: LYVISPAH is contraindicated in patients with hypersensitivity to baclofen.

Warnings and Precautions

• Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the dosage slowly when LYVISPAH is discontinued, unless the clinical situation justifies a rapid withdrawal.
• Neonatal withdrawal can occur; gradually reduce the dosage and discontinue LYVISPAH before delivery.
• LYVISPAH can cause drowsiness and sedation. Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system effects of LYVISPAH may be additive to those of alcohol and other CNS depressants.
• LYVISPAH can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions.
• LYVISPAH should be used with caution in patients who have had a stroke.

Adverse Reactions

• The most common adverse reactions (>1%) in patients treated with baclofen for spasticity are drowsiness, dizziness, weakness, nausea, confusion, hypotension, headache, insomnia, constipation, urinary frequency, and fatigue.

Drug Interactions

• LYVISPAH can cause CNS depression, including drowsiness and sedation, which may be an additive when used concomitantly with other CNS depressants or alcohol.

Use in Specific Populations

• Pregnancy: There are no adequate data on the developmental risks associated with the use of LYVISPAH in pregnant women. LYVISPAH should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Lactation: Nursing mothers should exercise caution, as oral baclofen has been shown to pass into milk at therapeutic doses. Withdrawal symptoms can occur in breastfed infants when maternal administration of LYVISPAH is stopped, or when breastfeeding is stopped.
• Pediatrics: Safety and effectiveness in pediatric patients below the age of 12 have not been established.
• Elderly Patients: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease of other drug therapy.
• Renal Impairment: Because baclofen is primarily excreted unchanged through the kidneys, LYVISPAH should be given with caution to patients with renal impairment, and it may be necessary to reduce the dosage.

For more information, refer to LYVISPAH prescribing information, located here.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements about LYVISPAH and its potential benefits, management’s intentions, plans, strategies, beliefs, expectations or forecasts regarding LYVISPAH and other products, including among other things: product research and development; discussions of future operations; expected operating results and financial performance, including projected revenues from LYVISPAH and other products; the Company’s strategy for growth; regulatory approvals and actions; market position, saturation, and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis, including the risks and uncertainties inherent in launching and commercializing LYVISPAH; the competition we face in the pharmaceutical industry in general, including from brand and generic drug product companies, and the impact of that competition on our ability to execute on pricing strategies; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods and any associated supply chain disruptions; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or curb Amneal’s ability to sell its products; the impact of severe weather; the impact of the ongoing COVID-19 pandemic; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn and inflation rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

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